Last Updated: May 10, 2026

PERIACTIN Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Periactin, and what generic alternatives are available?

Periactin is a drug marketed by Merck and is included in two NDAs.

The generic ingredient in PERIACTIN is cyproheptadine hydrochloride. There are six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the cyproheptadine hydrochloride profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for PERIACTIN?
  • What are the global sales for PERIACTIN?
  • What is Average Wholesale Price for PERIACTIN?
Summary for PERIACTIN
Recent Clinical Trials for PERIACTIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Kinnov TherapeuticsPhase 1
Shirley Ryan AbilityLabN/A
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)N/A

See all PERIACTIN clinical trials

US Patents and Regulatory Information for PERIACTIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck PERIACTIN cyproheptadine hydrochloride SYRUP;ORAL 013220-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Merck PERIACTIN cyproheptadine hydrochloride TABLET;ORAL 012649-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for PERIACTIN

Last updated: March 26, 2026

What is the current market landscape for PERIACTIN?

PERIACTIN (cyproheptadine) is an antihistamine primarily used to treat allergic reactions, certain migraine syndromes, and appetite stimulation. It was developed by Aventis (now part of Sanofi) and approved by the FDA in 1960. Despite its age, PERIACTIN maintains niche applications but faces a declining market share due to newer antihistamines and changing prescribing habits.

The global antihistamine market reached approximately USD 10.4 billion in 2022, with older drugs like PERIACTIN accounting for a fragment of this valuation. The drug's sales are more prominent in specific regions, including the US, Europe, and select Asian markets, where off-label uses sometimes sustain demand.

What are the key factors influencing PERIACTIN's market dynamics?

Competition from Newer Antihistamines

Newer drugs, such as loratadine, cetirizine, and fexofenadine, have become preferred choices due to their improved safety profiles, fewer sedative effects, and longer duration of action [1].

Drug Class Market Share (2022) Advantages Limitations
First-generation antihistamines 45% Cost-effective, off-label uses Sedation, anticholinergic side effects
Second-generation antihistamines 55% Non-sedating, more compliant Often more expensive

PERIACTIN’s therapeutic niche shrinks as physicians prefer these newer options, especially for long-term allergy management.

Regulatory and Labeling Constraints

PERIACTIN's use is limited or not approved for certain indications in some regions, constraining growth opportunities. Regulatory agencies focus on safety issues associated with first-generation antihistamines, impacting prescribing behaviors.

Off-label Use and Specialty Markets

Off-label applications include appetite stimulation in cancer patients or treating serotonin syndrome, which sustains modest demand. These applications are less influenced by general market trends and depend heavily on clinical practice patterns.

Patent and Market Exclusivity

PERIACTIN has been off patent for decades. No recent patent protections are active, exposing it to generic competition which reduces prices and margins.

Price Competition and Market Penetration

Generic manufacturers globally produce cyproheptadine at low prices, resulting in tight profit margins. Price competition limits revenue potential for existing suppliers.

What is the financial trajectory for PERIACTIN?

Revenue Trends

Since patent expiration, PERIACTIN's revenues have declined steadily. The drug's annual sales are estimated to be in the low hundreds of millions USD globally, with the US market contributing approximately USD 30 million to 50 million annually.

Year Estimated Global Sales (USD millions) Change YoY Major Drivers
2018 120 - Entry of newer drugs
2019 105 -12.5% Growing availability of alternatives
2020 90 -14.3% COVID-19 pandemic impacts
2021 80 -11.1% Continued market shift
2022 75 -6.25% Niche off-label demand persists

Cost Structure and Profitability

Manufacturing costs are low due to mature synthesis pathways, but low prices and declining sales margins limit profitability. Companies focus on cost containment and off-label market niche maintenance.

Investment and R&D Outlook

Limited R&D activity exists for PERIACTIN; focus for pharmaceutical companies centers on innovative antihistamines or targets with more significant growth prospects. Rare case applications and specialty markets might see incremental R&D, but large-scale investment is unlikely.

What market opportunities or threats exist?

Opportunities

  • Developing novel formulations or delivery systems for niche indications.
  • Expanding approved indications for appetite stimulation in cachexia.
  • Targeting regional markets with less competition from newer antihistamines.

Threats

  • Increased regulatory restrictions on first-generation antihistamines.
  • Price erosion from generic competition.
  • Clinical preference shifts toward non-sedating, long-acting alternatives.

What strategic considerations should industry players evaluate?

  • Focus on niche markets or off-label uses with existing demand.
  • Invest in formulations that improve patient compliance or target specific indications.
  • Monitor regulatory developments that could limit or expand uses.

Key Takeaways

PERIACTIN’s market is limited and declining, driven by competitive pressure from newer antihistamines, generic price erosion, and regulatory constraints. Its revenue streams rely heavily on niche, off-label, and specialty treatments. Future growth prospects are minimal without significant new indications or formulations. Industry players should approach the drug primarily with cost management in mind or as part of a broader portfolio targeting specialty markets.

FAQs

1. How does PERIACTIN compare in efficacy to newer antihistamines?
Newer antihistamines like cetirizine have comparable efficacy for allergy symptoms but better safety profiles—they cause less sedation and anticholinergic effects.

2. Is there potential for PERIACTIN to regain market share?
Limited; its main utility remains in niche off-label uses. Regulatory approvals for expanded indications would be necessary for significant market recovery.

3. What are the primary off-label uses sustaining PERIACTIN's demand?
Appetite stimulation in conditions such as cachexia or anorexia, and treatment of serotonin syndrome.

4. Which regions offer the most stable demand for PERIACTIN?
Regions with less access to newer antihistamines, including parts of Asia and certain European markets, maintain modest demand.

5. Are there ongoing developments or research supporting PERIACTIN?
No significant active research programs exist; focus has shifted to newer compounds and alternative therapies in allergy and appetite stimulation.

References

[1] Statista. (2022). Global antihistamine market share, 2022. Retrieved from https://www.statista.com

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.